5 дней назад
Associate Clinical Operations Compliance Director (Oncology)
168 500 - 238 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Clinical Operations Compliance Director (Oncology): Supporting compliant oncology clinical research execution with an accent on risk management, CAPA oversight, inspection readiness, and monitoring quality. Focus on building GCP training and quality metrics, maintaining audit-ready TMF records, leading mock inspections, and escalating site, data, and operational issues.
Location: Alameda, California, United States; office-based role
Salary: $168,500–$238,500 annually, adjusted by U.S. geographic market
Company
is a biotechnology company developing and supporting oncology medicines through clinical research and related scientific activities.
What you will do
- Support risk and issue management for Clinical Operations and ensure compliant study execution.
- Develop risk-management strategies and annual plans, collaborate with governance groups, and escalate operational and quality issues.
- Support CAPA owners with assignment, follow-up, completion tracking, and overdue-status updates.
- Partner with Quality Assurance, Clinical Development, Data Management, and other R&D functions.
- Lead one or more areas including GCP training, capability and analytics, BIMO and inspection readiness, or risk-based monitoring oversight.
- Maintain inspection readiness, support mock inspections, oversee CRO and monitoring quality, and escalate site and data issues.
Requirements
- Bachelor’s degree and at least 11 years of related experience, or a master’s degree and 9 years, or a doctoral degree and 5 years; equivalent combinations may be considered.
- Biotechnology or pharmaceutical industry experience is required.
- Current understanding of relevant scientific, legal, and regulatory requirements.
- Strong knowledge of biopharmaceutical regulations, standards, and best practices, including ICH GCP.
- Strong analytical, strategic-thinking, problem-solving, organizational, communication, presentation, and relationship-building skills.
- Advanced proficiency with Microsoft Excel, Word, PowerPoint, and Outlook.
Culture & Benefits
- Modern open-plan office designed for collaboration and creativity.
- Equipment provided, including dual monitors and ergonomic chairs.
- 401(k) plan with company contributions, medical, dental, vision, life, and disability insurance, and flexible spending accounts.
- Annual bonus eligibility, company stock purchase opportunities, and long-term incentives.
- Fifteen vacation days in the first year, 17 paid holidays, a company-wide winter shutdown, and up to 10 sick days annually.
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